Predicting Cancer Risk With Digital and Molecular Markers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biomaterial collection, BayPass mobile application.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Lung Cancer, Colorectal Cancer, Gynecologic Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Digital and Molecular Detection of Markers for Disease Risk Prediction, Improvement of Diagnostic Detection Accuracy and Implementation for Preventive Measures of Cancer - A Combined Case-control and Cohort Study
Overview
The goal of this study is to identify new markers to predict the risk of developing cancer, primarily breast cancer. For this purpose, researchers will compare data obtained from cancer patients and healthy individuals. If characteristic differences are identified, e.g. in biomarkers, life style or family history, this may indicate a person's increased risk of developing cancer.
Interventions
- Other Biomaterial collection
All subjects will be asked to provide biomaterial (blood or saliva) for bio marker screening and analysis. Additional biomaterial (breath, urin, stool) is optional. - Other BayPass mobile application
All subjects will be asked to use the study-specific mobile application "BayPass" to complete questionnaires and provide results from screening examinations over a course of 12 months.
Primary outcome measures
- Assessment of breast cancer risk by polygenic risk score in combination with app-based self-reported health behavior in the study population [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- Biological adult (at least 18 years old) women
- Written informed consent for study participation and processing of personal data
- Own smartphone that can run the BayPass mobile application and willingness to use said smartphone for study purposes
Additional inclusion criterion for case group:
- Pre-existing or current diagnosis of at least one of the following oncological diseases: breast cancer, lung cancer, colorectal cancer, gynecologic cancer (incl. ovarian cancer, endometrial cancer, cervical cancer, fallopian tube cancer, vaginal cancer and vulvar cancer)
Exclusion criteria
- Known infection with HIV (Human Immunodeficiency Virus), HepA (Hepatitis A), HepB (Hepatitis B), HepC (Hepatitis C) or active SARS-CoV2 (Severe acute respiratory syndrome coronavirus type 2) infection
- Acute severe or potentially life-threatening illness, except those specified in inclusion criterion #4
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Germany · 1 center
- DigiOnko Präventionsmobil — Please Refer to Project Homepage For Details (see Link Below)
Identifiers
NCT: NCT06962670 · PräDigt-08/22